Neuromuscular-Blocking Agents and Hypoxemia During Intubation in Infants (ROC-HYPOX)

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Enrolling; Phase 4

Conditions: Hypoxemia

Treatments: Drug: Rocuronium; Other: Sodium chloride 0.9%

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02589691

FDE_2014_25

Details and patient eligibility

About

The prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. These events occur partly during induction of anesthesia and are all the more frequent as the child is young.

The French recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. This recommendation is controversial In a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. This monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity.

The objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction

Enrollment: 412 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age <2 years
• indication of general anesthesia with tracheal intubation
• inhalational induction scheduled
• written informed consent of both parents

Exclusion criteria

• contra-indication to inhalational induction (full stomach)
• contra-indication to the use of rocuronium
• American Society of Anesthesiologists score (ASA) III or IV
• intracranial surgery
• parental refusal
• absence of affiliation to social security

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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412 participants in 2 patient groups, including a placebo group

Rocuronium

Experimental group

Description:

Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium

Treatment:

Drug: Rocuronium

Placebo

Placebo Comparator group

Description:

Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9%

Treatment:

Other: Sodium chloride 0.9%